Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)

JRCT ID: jRCT2041240131

Registered date:25/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: APS, BP, BS, DM, IMNM, and ITP (Please refer to "Others" section for abbreviations)
• Date of first enrollment: 09/12/2024
• Target sample size: 144
• Countries of recruitment: Taiwan,Japan,Canada,Japan,Australia,Japan,Turkey,Japan,Austria,Japan,Croatia,Japan,Czech,Japan,Bulgaria,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Spain,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan
• Study type: Interventional
• Intervention(s): RAY121: Injection

Outcome(s)

Primary Outcome

safety
- Incidence, severity, and causal relationship of AEs including SAEs
- Change in laboratory test results, vital signs, and electrocardiogram

Secondary Outcome

efficacy, phamacokinetics, phamacodynamics, other
- Serum RAY121 concentration and relevant PK parameters
- Complement related PD biomarkers
- Prevalence and incidence of anti-RAY121 antibodies
- Disease specific secondary efficacy endpoints defined in the protocol

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Signed informed consent form
2. Have completed 4 doses of RAY121 administrations in RAY902CT trial and shown clinical responses
3. Ability to comply with the study protocol
4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods during the treatment period and 20 weeks (140 days) after the last dose of RAY121
5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclude criteria

1. History of anaphylaxis or hypersensitivity to a biologic agent
2. Known active infection with encapsuled bacteria
3. History of Neisseria meningitidis infection
4. Planned surgery
5. Pregnant or breastfeeding, or intending to become pregnant
6. Clinically significant ECG abnormalities
7. Illicit drug or alcohol abuse
8. Known or suspected immune deficiency
9. Treatment with investigational therapy other than RAY121
10. Vaccination with a live vaccine within 4 weeks

Related Information

• Primary Sponsor: Hashimoto Akiko
• Secondary ID(s): 2024-511346-39-00